A Prospective, Multicenter, Randomized, Open-label, Feasibility, Safety and Efficacy Study of Renal Denervation in Patients With Chronic Heart Failure (CHF)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 22
- Primary Endpoint
- Safety of renal denervation with the Symplicity Catheter System with special consideration of clinically significant periprocedural adverse events in CHF patients
Study Overview
Brief Summary
The purpose of the trial is to investigate the safety and effectiveness of renal denervation for the treatment of chronic heart failure (CHF).
Detailed Description
Heart failure is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Therapies to ameliorate the high mortality and morbidity of heart failure have focused on abrogation of activated neurohormonal systems associated with this condition. These systems include the renin-angiotensin-aldosterone system and the sympathetic nervous system.
Strategies to ameliorate sympathetic activation have primarily focused on blockade of the beta-adrenoceptors that mediate the adverse effects of activation of this system upon the myocardium. This has been a highly successful strategy with beta-blockers resulting in an approximately 35% reduction in mortality as well as improvements in hospitalization and quality of life and attenuation of disease progression.
However, less than full blockade of the effects of the sympathetic nervous system is achieved with the use of conventional doses of beta-blockers. Moreover, a not insignificant fraction of patients are unable to tolerate beta-blockers or are not able to have them up-titrated to target effective doses, in large part because of the systemic nature of these agents, whereas renal denervation allows the selective removal of the kidney's contribution to central sympathetic drive without blunting other compensatory mechanisms.
The renin-angiotensin-aldosterone axis has also been found to be a key system involved in heart failure disease progression and it too may be inhibited by renal sympathetic denervation.
Therefore, a clear need exists for further strategies to beneficially manipulate the sympathetic activation that is characteristic of the heart failure disease process.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •New York Heart Association Class II-III symptoms of chronic heart failure
- •Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction in a range of 10%- 40%.
- •GFR >30 mL/min/1.73m2
- •Brain natriuretic Peptide (BNP) >100 pg/ml or N terminal (NT)-Pro-BNP >400 pg/ml.
- •Optimal medical therapy according to current guidelines for CHF management. Treatment for HF must be stable (including drug and dose) for at least 4 weeks prior to procedure, with the exception of diuretics, where stability is required for at least 2 weeks.
Exclusion Criteria
- •Renal arterial anatomy that is ineligible for treatment
- •CHF caused by pericarditis or by acute myocarditis or by endocrine diseases.
- •Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within three 12 weeks of the screening visit.
- •Office systolic BP at screening less than 90 mmHg
- •Primary pulmonary hypertension.
- •Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
- •Major surgery, including bariatric surgery, in the previous 12 weeks before baseline.
- •Contrast media administration in the previous 30 days before baseline.
- •Known hypersensitivity to material of the Symplicity Catheter.
- •Inpatient hospitalization for decompensated HF in the previous 60 days before baseline.
Outcomes
Primary Outcomes
Safety of renal denervation with the Symplicity Catheter System with special consideration of clinically significant periprocedural adverse events in CHF patients
Time Frame: Baseline visit for treatment group, month 6 visit for control group
Number of complications associated with the delivery and/or use of the Symplicity Catheter (e.g., vascular injury and bleeding complications, access site hematoma, etc.). Vital signs, blood and urine measurements taken before, during and after the denervation procedure
Secondary Outcomes
- Physiologic response to renal denervation: ventricular function(From denervation prodecure to 6 months after renal denervation procedure)
- Physiologic Response to renal denervation: renal function(From denervation prodecure to 6 months after renal denervation procedure)
- Physiologic Response to renal denervation: symptomatology/Quality of Life(From denervation prodecure to 6 months after renal denervation procedure)
- Physiologic Response to renal denervation: additional parameters(From denervation prodecure to 6 months after renal denervation procedure)